Kornimate/medical-research-clean huggingface dataset:
clinical trial of yhd1119 in patients with peripheral neuropathic pain

Conditions: Peripheral Neuropathic Pain

Summary: a randomized, double-blind, active-controlled, multi-center, phase 3 trial to compare the safety and efficacy between yhd1119 and pregabalin in patients with peripheral neuropathic pain


Eligibility criteria:
inclusion criteria: * signed informed consent * hba1c ≤ 9.5% diabetes mellitus patients with pain over 6 months in diabetic peripheral neuropathy or postherpetic neuralgia patients at least 3 months pain after diagnosis of skin rash due to herpes zooster exclusion criteria: * have brittle diabetes mellitus
semaphorins 3a and 4d levels in heart failure patients

Conditions: Heart Failure

Summary: this study hypothesis is that semaphorins 3a and 4d levels are overexpressed in patients with heart failure. study protocol: hospitallized patients with new onset or previously diagnosed heart failure will be recruited to the study. control group will include healthy people with no medical records or chronic treatment at the same age range. after signing an informed constent form, full medical history and blood samples will be collected. a second blood sample will be collected 8 weeks later, assuming the patient was discharged and not hospitalized since than. the blood samples will be analyzed by bnai zion medical center immunology labs for the above semaphorins levels in the heart failure group and control group. statistical analysis will then commence for possible correlatoion with different clinical parameters.

in few previous published studies, semaphorins 3a levels are overexpressed in patients with heart failure. the aim of our study is the compare semaphorin 3a and 4d in patients with acute decompansated heart failure with healthy donors. second aim is to compare semaphorin level in the same patients in time of hospitalization and few weeks later when the heart failure presumingly controled. statistical analysis will then commense for possible correlatoion with different clinical parameters like nyha (new york heart association) status of the patient, lenghts of hospitalization and bnp (brain natriuretic peptide) levels at time of admition.

Eligibility criteria:
inclusion criteria: * patients with new onset or previously diagnosed heart failure. * heart failure diagnosis can be based on clinical judgment, echocardiography or elevated bnp levels exclusion criteria: * patients with acute myocardial infarction diagnosed clinicly and labratory
the trauma recovery and empowerment model for treating post-traumatic stress disorder in women

Conditions: Post-Traumatic Stress Disorder; Mental Disorders; Depression

Summary: this study will determine the effectiveness of the trauma recovery and empowerment model in reducing the severity of post-traumatic stress disorder symptoms in women with mental disorders and who have experienced sexual or physical abuse.

post-traumatic stress disorder (ptsd) is an anxiety disorder that can develop after exposure to a terrifying event in which grave physical harm occurred or was threatened. rates of ptsd are extremely high among people with severe mental disorders and such individuals find themselves at increased risk for depression, substance abuse, and poor overall health. in turn, these issues lead to high rates of utilization of mental health services. unfortunately, there is currently a lack of effective trauma treatments that can be implemented in routine mental health settings. trauma recovery and empowerment model (trem) is a group-based intervention that addresses ptsd and other closely related consequences of sexual and physical abuse among women with severe mental disorders. this study will determine the effectiveness of trem in reducing the severity of ptsd symptoms in women with mental disorders who have experienced sexual or physical abuse. participants in this open label study will be randomly assigned to receive either usual care alone or usual care combined with trem for 18 months. usual care will include medication, case management, and therapy administered by a primary clinician. participants assigned to usual care will report to the study site at least once a week, or as often as necessary. participants assigned to usual care plus trem will also be assigned to a primary clinician and will receive usual care as often as necessary. in addition, trem participants will take part in 29 group sessions that will focus on increasing self-esteem and trauma-coping skills and reducing self-blame. ptsd symptom severity, trauma beliefs, depressive symptoms, substance use, and mental health service utilization will be measured at months 6, 12, and 18 for all participants.

Eligibility criteria:
inclusion criteria: * history of physical and/or sexual abuse * diagnosis of a severe mental disorder * diagnosis of ptsd with a symptom severity score of 21 or higher exclusion criteria: * severe developmental disabilities or organic brain damage

Keywords: ptsd physical abuse sexual abuse women trauma group therapy substance abuse
high-dose 3f8/gm-csf immunotherapy plus 13-cis-retinoic acid for consolidation of first remission after myeloablative therapy and autologous stem-cell transplantation

Conditions: Neuroblastoma

Summary: the purpose of this study is to see if high-dose 3f8 combined with gm-csf is better than standard dose 3f8 in treating neuroblastoma. another purpose of the study is to find out what effects, good and/or bad, 3f8 has on cancer. the investigators also want to see if the antibody works against a very small amount of neuroblastoma (minimal residual disease) that is left in the bone marrow.


Eligibility criteria:
inclusion criteria: * diagnosis of nb as defined by a) histopathology (confirmed by the mskcc department of pathology), or b) bm metastases or mibg-avid lesion(s) plus high urine catecholamine levels. * high-risk nb as defined by risk-related treatment guidelines1 and the international nb staging system,89 i.e., stage 4 with (any age) or without (\> or = to 18 months of age) mycn amplification, mycn-amplified stage 2 or stage 3 (any age), or mycn-amplified stage 4s. * the patients are post-stem cell transplantation and in first cr/vgpr, including no measurable mibg-avid soft tissue tumor assessable for response. * signed informed consent indicating awareness of the investigational nature of this program. exclusion criteria: * creatinine \> 3.0 mg/dl * alt, ast and alkaline phosphatase \> 5.0 times the upper limit of normal * bilirubin \> 3.0 mg/dl * patients with grade 3 or higher toxicities (using the ctcae v3.0) related to cardiac, neurological, pulmonary or gastrointestinal function as determined by physical exam. patients must have normal blood pressure for age. * progressive disease * history of allergy to mouse proteins. * active life-threatening infection. * human anti-mouse antibody (hama) titer \>1000 elisa units/ml. * inability to comply with protocol requirements

Keywords: gm-csf mab 3f8 retinoic acid (cis-9 & 13) 09-158
"program "cerdanya on fitness" to improve the lifestyle of people with obesity in cerdanya (cf).

Conditions: Obesity

Summary: to evaluate the effectiveness of an intervention program called "cerdanya on fitness" based on the prescription of physical activity, healthy nutritional habits and the promotion of positive mental health, adapted to people with obesity to improve their lifestyle and psychoemotional wellbeing

previous phase:presentation of the protocol to doctors and nurses of the primary health care center. phase 1: after being informed about the study and the possible risks, all patients who give their written informed consent will undergo. -1) 4 weeks of screening to determine eligibility to enter the study. referral of patients who meet the inclusion/exclusion criteria to enter the cerdanya on fitness program by the nursing consultation. phase i protocol data collection (physical activity scale, positive mental health scale, mediterranean diet scale, sociodemographic variables will also be collected week 0) patients who meet the eligibility requirements will be randomized in a non-blinded fashion. (control group and research group) (5 weeks) weeks 1-2: initial assessment of physical fitness and dietary habits in the intervention group (blood test- stress test- anthropometry) week 3-39: implementation of the intervention (nutritional, physical activity and psychosocial) to the intervention group. the control group will continue with the usual nursing controls in the primary care center. 40-41 week: final evaluation of the physical condition and eating habits of the intervention group (blood test, stress test, anthropometry): final data collection of the control and intervention group (physical activity scale, positive mental health scale, mediterranean diet scale). translated with www.deepl.com/translator (free version)

Eligibility criteria:
inclusion criteria: * \>18 years * body mass index 30-40 exclusion criteria: * serious cognitive impairment * serious mental disorder * impossibility of performing physical activity for medical diagnosis (iam \< 3 months, hemorrhagic stroke \< 3 months, major surgery \< 3 months) * severe mobility difficulties (people with use of devices such as cane, walker, wheelchair..)

Keywords: physical activity, healthy lifestyle mental health
lifestyle modification program for lung cancer patients - physical activity preference

Conditions: Lung Cancer

Summary: lung cancer is the leading cause of deaths in the world. engagement in physical activity can provide important benefits for cancer patients. the current study is a cross-sectional questionnaire survey and in-depth interview to understand the physical activity preferences of patients with lung cancer. this process could help to develop a lifestyle modification program based on our patients' needs and preferences.

lung cancer is one of the most common cancer globally and locally. patients with lung cancer are in a uniquely difficult situation in their disease, comorbidities, and treatment that may lead to worsened symptoms and many negative health consequences, including fatigue, irritability, and impaired daytime functioning. physical activity (pa) is defined as 'any bodily movement produced by skeletal muscle that results in energy expenditure'. several health benefits of increased pa have been reported for people with cancer. pa plays a critical role across the cancer trajectory, from prevention through to post-diagnosis and has been proposed as an alternative for improving physical and psychosocial health outcomes, reducing cancer recurrence, and cancer-specific and all-cause mortality. however, most of the findings were predominantly in breast and colorectal cancers. the pa dosage required to attain health benefits across these cancer groups is not uniform, nor is it clear whether the results can be applied to other groups of people with cancer. the current study includes a cross-sectional questionnaire survey and an in-depth interview. it aims to understand the current physical activity practice and preference of patients with lung cancer, which could help to develop a lifestyle modification program based on our patients' needs and preferences.

Eligibility criteria:
inclusion criteria: * aged 18 years and above; * diagnosis with non-small cell lung cancer * general condition stable, either is undergoing or finished treatment * able to speak and read chinese * able to complete the self-administered questionnaire * mental, cognitive and physically fit for joining the trial as determined by the clinician or responsible investigator exclusion criteria: * mentally unfit for answering questionnaire * unable to give informed consent

Keywords: lifestyle modification lung cancer preferences
rapid diagnostic test for influenza

Conditions: Influenza

Summary: the primary objective of this study is to evaluate the performance of the msd® influenza test in detecting influenza a and influenza b in subjects presenting with influenza-like-illness (ili).

this is a multicenter, prospective study to evaluate the performance of the msd influenza test for the detection and differentiation of influenza a (including a/h1, a/h3, and a/h5 subtypes) and influenza b. nasal swabs from subjects presenting at the clinical care facility with ili will be collected and tested on the msd influenza test. results from the test will be compared to results obtained from viral culture performed on a second nasal swab at a reference laboratory.

Eligibility criteria:
inclusion criteria: * any subject (all ages) presenting with ili (defined as fever \[subjective or documented\] and cough or sore throat), and suspected of having influenza. * subject (parent, guardian, or authorized legal representative) gives informed consent to the study, and provides signed authorization for use and disclosure of protected health information. exclusion criteria: * subjects who had prior nasal wash/aspirate or nasopharyngeal wash/aspirate specimens collected for routine health-care purposes within the same suspected influenza infection episode. * unable to collect nasal and throat swab. * severely ill patient without a family relative to provide informed consent.

Keywords: influenza infections orthomyxoviridae infections influenza human
a study of ak104/placebo combined with chemoradiotherapy for the treatment of locally advanced cervical cancer

Conditions: Locally Advanced Cervical Carcinoma

Summary: this study is to evaluate the efficacy and safety of ak104 plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer


Eligibility criteria:
inclusion criteria: 1. signs the written informed consent form 2. ecog 0-1 3. life expectancy ≥ 3 months. 4. the histological types include squamous cell carcinoma,adenocarcinoma, or adenosquamous cell carcinoma; 5. locally advanced cervical cancer (lacc): the international federation of gynecology and obstetrics (figo) 2018 stage 3a-4a 6. at least one measurable tumor lesion per recist v1.1 7. adequate organ function as assessed in the laboratory tests exclusion criteria: 1. subjects with other histopathological types of cervical cancer, such as small cell carcinoma, sarcoma, etc. 2. figo 2018 ivb 3. subjects who had previously undergone total hysterectomy 4. subjects who cannot receive brachytherapy 5. subjects with other active malignancies within 2 years prior to randomization 6. clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the investigator 7. any prior treatments targeting the mechanism of tumor immunity, such as immune checkpoint inhibitors (e.g., anti-pd-1 antibody, anti-pdl1 antibody, anti-ctla-4 antibody, etc.), or therapy against immune costimulatory factors (e.g., antibodies directed against icos, cd40,cd137, gitr, ox40 targets, etc). 8. subjects who require systemic treatment with glucocorticoid (\>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to randomization; 9. major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study 10. use of live vaccines within 4 weeks prior to randomization 11. active or potentially recurrent autoimmune disease 12. known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (hiv) antibodies 13. known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation 14. known history of interstitial lung disease or non-infectious pneumonitis 15. pregnant or lactating women. 16. any condition that, in the opinion of the investigator, may result in a risk when receiving the study drug.
guiding sufentanil administration with skin conductance in mechanically ventilated intensive care patients

Conditions: Nociceptive Pain

Summary: opioid administration in mechanically ventilated patients in the intensive care unit (icu) is essential to maintaining patient respiratory and hemodynamic stability. mechanical ventilation is a persistently nociceptive event that can continuously causes discomfort in the trachealy intubated patient. this can lead to patient-ventilator dyssynchrony, tachycardia, hypertension, and their associated complications. opioids blunt respiratory drive, which facilitates mechanical ventilation, and decrease the sympathetic response to nociception. however, excessive opiate administration is associated with many adverse events, including respiratory depression, delirium, ileus, nausea, and vomiting. currently, the standard administration in our institution of sufentanil, a potent opiate, consists of continuous infusions of 0.15µg/kg/h to 0.3µg/kg/h. mechanically ventilated patients are unable to speak and are often sedated. this greatly impacts the patient's capacity to communicate pain. the use of a nociceptive monitor may be a possible solution. skin conductance monitoring (pain monitor, med-storm, norway), measures the peaks per second of electrical conduction. this non hemodynamic monitor uses skin conduction as a surrogate to nociception (i.e., the patient's unconscious response to a noxious stimulus). it may consequently guide opioid administration in icu patients towards and avoid the consequences of excessive or inadequate antinociception.


Eligibility criteria:
inclusion criteria: * adult patient admitted to the icu requiring endotracheal intubation, antinociception, and sedation exclusion criteria: * traumatic brain injury * use of ketamine, dexmedetomidine, or clonidine * pregnancy
nasal specimen collection study in patients with ili and/or ari in an outpatient setting

Conditions: Influenza-like Illness; Influenzal Acute Respiratory Infection

Summary: this is a prospective specimen collection study targeting patients presenting with influenza like illness (ili) and/or acute respiratory infection (ari) in an out-patient setting. a non-invasive, user friendly sampling technique, using midturbinate flocked swabs will be used. these nasal swabs will be collected in different volumes of viral transport media (0.5ml and 3.0ml), for different dilution range of the viruses present in the collected biological specimen. the collection of nasal swabs samples will support the optimization of point of care detection methods for respiratory viruses responsible for ili and/or ari.


Eligibility criteria:
inclusion criteria: * male or female * all ages * valid informed consent and/or assent, where applicable * onset of ili and/or ari within the last 3 days (≤ 72h) * patient presented with ili and/or ari exclusion criteria: * invalid informed consent and/or assent * onset of ili and/or ari was \> 3 days (\> 72 h) * patient did not presented with neither ili or ari * patient received intranasal attenuated influenza virus in last 3 weeks (example flumist®, fluenz®) * patient received treatment with influenza direct antivirals in the last 7 days

Keywords: influenza-like-illness nasal swabs detection of influenza sensitivity of detection assays
visual outcomes of tecnis symfony opti-blue edof intraocular lens (iol)

Conditions: Cataract

Summary: tecnis symfony optiblue edof iol is the latest version of tecnis symfony iol with a violet light filter (vlf), which blocks short-wavelength light and improves the quality of vision while minimizing visual disturbances. the present study aims to assess the visual outcomes at distance, intermediate, and near following cataract surgery and implantation of tecnis symfony optiblue iol in patients with retinal comorbidities.

extended depth of focus (edof) iols, on the other hand, are based on the principle of creating a single-elongated focal point to enhance the depth of focus (dof) and eliminate the overlapping of near and far images caused by traditional multifocal iols, thus generating a lower incidence of halos and glare. the tecnis symfony (johnson \& johnson vision) edof iol incorporates a diffractive echelette design to increase the range of vision. the achromatic technology corrects chromatic aberration and increases retinal image contrast. the latest version of the tecnis symfony lens (dxr00v/zxr00v) has the optiblue violet light filter (vlf), which blocks short-wavelength light. violet light filtration reduces light scatter, improving contrast and reducing nighttime visual disturbances such as halo, glare, and starbursts. as such, the present study aims to assess the visual outcomes at distance, intermediate and near following implantation of violet light filtering tecnis symfony optiblue edof iols in patients with retinal comorbidities undergoing cataract surgery.

Eligibility criteria:
inclusion criteria: * patients diagnosed with retinal comorbidities, with visual acuity potential of 20/30 or better, who wish to undergo bilateral cataract surgery and are willing to provide written informed consent and adhere to study requirements. exclusion criteria: * corneal dystrophies * central corneal scarring * keratoconus * proliferative diabetic retinopathy * exudative macular degeneration * zonular weakness * pseudoexfoliation * fovea-involving atrophy * severe dry eye * amblyopia * pupil abnormalities * need for an iol outside the range of +5.0 d to +34.0 d or cylinder power over 3.75 d * patients who have undergone prior cataract surgery and iol implantation in either eye; had prior corneal refractive or corneal transplantation surgery; diabetics post-vitrectomy; or who have a history of macula-off retinal detachment will also be excluded.

Keywords: retinal comorbidity tecnis symfony optiblue intraocular lens
supplementation of phosphatidylserine (ps) and n-3 long chain fatty acids (epa, dha) in children with adhd

Conditions: Attention-Deficit/Hyperactivity Disorder

Summary: to determine whether supplementation of omega-3 long-chain polyunsaturated fatty acid conjugated to phosphatidylserine rather than triglycerides (fish oil) could affect attention-deficit/hyperactivity disorder symptoms in children.

background attention-deficit/hyperactivity disorder (adhd) encompasses a broad constellation of behavioral and learning problems, clinically describes inattentive, impulsive, and/or hyperactive children. these patients are characterized by low blood lc-pufa (lc-pufa) levels; however the lc-pufa supplementation effect on adhd symptoms is not clear. methods eighty-three adhd children (3:1 boys:girls), 8-13 years old, were assigned in a randomized, double-blind, placebo-controlled parallel design to receive 250 mg/d of eicosapentaenoic acid + docosahexaenoic acid provided as phosphatidylserine (300 mg/d ps-omega3), or fish oil or placebo for 3 months. stimulant medication or other dietary supplements were prohibited. the measured outcomes were inattention and impulsivity, evaluated by test of variables of attention (tova) and blood lipids profile.

Eligibility criteria:
inclusion criteria: * 8 and 13 years of age; diagnosed as having adhd; otherwise healthy; exclusion criteria: * significant sensory or neurological limitations, epilepsy, mental retardation, psychosis, or pervasive developmental disorder; medications with known central nervous system effects such as tranquilizers, antidepressants, stimulants (including methylphenidate and amphetamines), sedating antihistamines and some asthma medications and dietary supplements but vitamins

Keywords: behavioral problems learning problems inattentive impulsive hyperactive children phosphatidylserine long-chain polyunsaturated fatty acid eicosapentaenoic acid docosahexaenoic acid omega3:omega6 ratio eicosapentaenoic acid:arachidonic acid ratio test of variables of attention adhd index scores